Edirol (eldecalcitol) / Roche, Taisho - LARVOL DELTA

Repeated romosozumab with short-term ibandronate sequencing in high-risk osteoporosis: a retrospective single-center cohort study. (PubMed, JBMR Plus) - "All patients received eldecalcitol 0.75 μg daily. Repeated courses were accompanied by longitudinal improvements in recorded skeletal measures and bone turnover markers. Because this was an uncontrolled retrospective study and patient-level baseline data for the 19 patients who discontinued were unavailable in the analytical dataset, the findings should be considered descriptive and hypothesis-generating."

Journal • Retrospective data • Cardiovascular • Endocrine Disorders • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Efficacy and Safety of Eldecalcitol versus Calcitriol in Postmenopausal Women with Osteopenia or Osteoporosis: A Multi-center, Open-Label, Randomized, Active-Controlled Trial (ASBMR 2026) - No abstract available

Clinical • Osteoporosis • Rheumatology

Eldecalcitol in older adults with kidney vulnerability: a narrative review of risk-based use, dose adjustment, and monitoring. (PubMed, Clin Exp Nephrol) - "Eldecalcitol should be withheld during poor intake, dehydration, or acute illness and reconsidered when calcium rises or kidney function deteriorates. Safe use therefore requires risk-based selection rather than passive routine-dose prescribing, planned biochemical follow-up, and explicit treatment reassessment."

Journal • Review • Acute Kidney Injury • Chronic Kidney Disease • Endocrine Disorders • Metabolic Disorders • Musculoskeletal Diseases • Nephrology • Orthopedics • Osteoporosis • Renal Disease • Rheumatology • CST3

Comparison of Efficacy and Safety of Denosumab with Eldecalcitol or Native Vitamin D in Postmenopausal Chinese Women with Osteoporosis (ESCORT): A Randomized Controlled Trial. (PubMed, J Clin Med) - P4 | " Combination therapy with denosumab and eldecalcitol improved LS-BMD more effectively than denosumab with native vitamin D and calcium in postmenopausal Chinese women with osteoporosis. Clinical trial number: ClinicalTrials.gov identifier NCT05884372, registered on 1 June 2023."

Clinical • Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Romosozumab Treatment After Parathyroidectomy for Primary Hyperparathyroidism-Complicated Osteoporosis: A Two-Case Report. (PubMed, AACE Endocrinol Diabetes) - "Parathyroidectomy increases bone mineral density (BMD) by 3% to 4% in patients with primary hyperparathyroidism (PHPT); however, limited studies have demonstrated the effect of postoperative medical therapy, particularly with bisphosphonate and denosumab, on BMD...After parathyroidectomy and 5-year treatment with eldecalcitol and raloxifene, T-scores were -3.3 and -5.6 in the LS and DR, respectively...These cases suggest that postoperative romosozumab therapy may be a potential therapeutic option in patients with PHPT and osteoporosis. Romosozumab may be a promising postoperative therapy for patients with PHPT and osteoporosis."

Journal • Endocrine Disorders • Metabolic Disorders • Osteoporosis • Rheumatology

Bone density changes in patients treated with aromatase inhibitors for 5 years (JBCS 2026) - "Therefore, we investigated changes in bone mineral density in patients receiving anastrozole (ANA) or letrozole (LET)...As a general rule, in cases of osteopenia, an active vitamin D preparation called eldecalcitol (Vit D) is administered in combination, and in cases of osteoporosis, a bisphosphonate (Bis) or denosumab (Deno) is administered in combination...The median age, median bone mineral density before AI administration, and median bone mineral density after 5 years of AI administration were as follows: Group N: 64 years old, 91%, and 81%; Group V: 67 years old, 78.5%, and 74.5%; Group B: 71 years old, 63%, and 65%; and Group D: 73 years old, 70%, and 73%. These results suggest that, when administering AI, it may be possible to maintain bone mineral density to some extent by co-administering bisphosphonates or denosumab to patients with low bone mineral density."

Clinical • Breast Cancer • Solid Tumor

Eldecalcitol and calcium supplementation in Chinese women with postmenopausal osteoporosis: a prospective observational cohort study. (PubMed, J Bone Miner Metab) - P | "This study confirmed the real-world safety profile of eldecalcitol in a large population of Chinese women with postmenopausal osteoporosis. Hypercalcemia incidence was higher in patients with compared to without calcium supplementation, indicating that concomitant eldecalcitol and calcium should be carefully considered."

Journal • Observational data • Endocrine Disorders • Metabolic Disorders • Osteoporosis • Renal Calculi • Rheumatology • Urolithiasis

BEYOND MORPHOLOGY: A FLOW CYTOMETRIC RISK SCORE FOR IMMEDIATE IDENTIFICATION OF BCR3-GENOTYPE AND FATAL OUTCOMES IN ACUTE PROMYELOCYTIC LEUKEMIA (EHA 2026) - "This signature successfully identi(ed 71% of high-risk patients at the hour of diagnosis, effectively "pre-empting" molecular confirmation. . Summary/Conclusion Our study identifies a specific MFC "biological snapshot" (Low-SSC/CD38+/HLA-DR+) that functions as a robust, zero-cost, and real-time surrogate for the bcr3 isoform and fatal APL biology. This "MFC-Risk Signature" allows clinicians to bypass the molecular waiting period, justifying immediate therapeutic escalation—such as upfront ATRA (All-Trans Retinoic Acid) or intensified supportive care—in patients at highest risk of early death."

IO biomarker • Acute Promyelocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • CD34 • CD38 • PML

Mechanistic actions of eldecalcitol and alfacalcidol across the muscle-metabolic axis: A selectivity perspective in sarcopenia and type 2 diabetes. (PubMed, iScience) - "While preclinical studies suggest context-dependent modulation of inflammatory and anabolic pathways, direct comparative analyses demonstrating ligand-specific VDR transcriptional bias in human skeletal muscle remain lacking. Accordingly, the concept of functional selectivity is presented as a biologically plausible but as yet unproven framework, intended to guide future translational investigations."

Journal • Review • Diabetes • Inflammation • Metabolic Disorders • Sarcopenia • Type 2 Diabetes Mellitus

Potential Modulation of ED-71 in Regulating H3K18 histone lactylation to Suppress osteoclast differentiation and Alleviate Postmenopausal osteoporosis. (PubMed, Biochem Pharmacol) - "Furthermore, we demonstrated that ED-71 treatment effectively disrupts this regulatory axis by suppressing glycolysis, reducing H3K18la levels, and alleviating ER stress, inhibiting SOCE and restoring bone homeostasis. Our findings provide novel insights into the pathogenesis of PMOP and establish ED-71 as a promising multi-target therapeutic agent."

Journal • Osteoporosis • Rheumatology

Eldecalcitol enhances osteo/odontogenic differentiation and mineralized matrix formation via redox modulation in human dental pulp stem cells. (PubMed, Tissue Cell) - "ELD promotes osteo/odontogenic differentiation and mineralized matrix formation in hDPSCs through dose-dependent modulation of redox balance and cellular functionality. Together, these findings underscore the presence of a defined therapeutic concentration window and support the potential use of ELD as a biomodulatory molecule in regenerative endodontic approaches."

Journal • ALPL • ANXA5 • COL1A1

Prior treatment, not vitamin D, predicts romosozumab response in 314 osteoporosis patients: A retrospective cohort study. (PubMed, Bone Rep) - "Although calcium and vitamin D supplementation is recommended with romosozumab therapy for postmenopausal osteoporosis, real-world evidence examining the impact of vitamin D formulation, dose, and prior treatment history on the treatment response remains limited. Eldecalcitol 0.5 μg appears to be optimal for treatment-naïve patients with osteoporosis. Selection bias in vitamin D prescriptions must be considered when interpreting real-world treatment outcomes."

Journal • Retrospective data • Osteoporosis • Rheumatology

Sympathetic overactivity-induced type H endothelial cell senescence contributes to the impairment of vascularized osteogenesis by PKM2-mediated glycolysis in preclinical stages of Alzheimer's mice. (PubMed, Bone) - "Furthermore, our results also showed that combination therapy with oryzanol (sympathetic modulator) and eldecalcitol (senolytic) synergistically restores vascularized osteogenesis by targeting both neurovascular and metabolic axes. These findings establish a pathogenic role for sympathetic hyperactivity in AD-related skeletal dysfunction and highlight a therapeutic strategy targeting EC senescence and glycolytic metabolism."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Metabolic Disorders • Osteoporosis • PKM

Vitamin D Receptor Signaling and Ligand Modulation: Molecular Mechanisms and Therapeutic Implications. (PubMed, Int J Mol Sci) - "However, compounds like eldecalcitol are effective in osteoporosis, especially in low-calcium-intake populations...These agents may enable anti-inflammatory or anti-proliferative actions without calcemic risks. Understanding the nuanced biology of vitamin D and its analogs offers new avenues for therapeutic intervention beyond bone metabolism, including managing hyperparathyroidism, granulomatous diseases, and inflammation-associated disorders."

Journal • Review • Chronic Kidney Disease • Diabetes • Endocrine Disorders • Infectious Disease • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Rheumatology

Relationship between Hypercalcemia and Renal Function with Eldecalcitol (PubMed, Yakugaku Zasshi) - "These findings indicate that a low baseline eGFR predisposes patients to hypercalcemia during ELD therapy. In clinical practice, patients with baseline eGFR ≤45.9 mL/min may require more frequent calcium monitoring and consideration of alternative treatments such as alfacalcidol, with close collaboration between physicians and pharmacists."

Journal • Endocrine Disorders • Metabolic Disorders • Nephrology • Osteoporosis • Renal Disease • Rheumatology

Trends in the incidence of secondary hip fractures and osteoporosis treatment in Japan (FY2012-FY2023). (PubMed, J Bone Miner Metab) - "The medication administration rate has consistently increased. The incidence of secondary fractures decreased from FY2019 but then increased in FY2021 due to the impact of the coronavirus disease 2019 (COVID-19) pandemic. However, in FY2022, this increase was mitigated by the introduction of management fees. It is anticipated that the incidence of secondary fractures will decline again due to a further increase in medication rates following the COVID-19 pandemic."

Journal • Infectious Disease • Musculoskeletal Diseases • Novel Coronavirus Disease • Orthopedics • Osteoporosis • Respiratory Diseases • Rheumatology

Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes (clinicaltrials.gov) - P=N/A | N=358 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital | Trial completion date: Jul 2026 ➔ Jul 2027 | Trial primary completion date: Jul 2026 ➔ Jul 2027

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology • Type 2 Diabetes Mellitus

Comparative effectiveness of bone-protective interventions for aromatase inhibitors-induced bone loss in postmenopausal women with early breast cancer: a network meta-analysis. (PubMed, Front Oncol) - "Seventeen RCTs involving 6,932 postmenopausal patients were included, comparing six interventions: denosumab, alendronate, zoledronic acid, ibandronate, risedronate, and eldecalcitol plus risedronate. Further head-to-head trials are warranted to validate optimal treatment sequences. PROSPERO (CRD420251008444)."

HEOR • Journal • Retrospective data • Review • Breast Cancer • Oncology • Solid Tumor

Trends in the incidence of hip fractures and osteoporosis treatment in Japan (FY2012-FY2023). (PubMed, Arch Osteoporos) - "Although the number of patients with hip fractures increased until FY2017, it remained stagnant over the next 3 years, possibly due to enhanced treatment rates and changed medications. However, the number of patients with hip fractures again increased from FY2021 onwards, coinciding with the coronavirus disease 2019 (COVID-19) pandemic in Japan. Post-COVID-19, increasing adherence to effective osteoporosis medications may curb or even reduce the number of patients with hip fractures."

Journal • Infectious Disease • Musculoskeletal Diseases • Novel Coronavirus Disease • Orthopedics • Osteoporosis • Respiratory Diseases • Rheumatology

ED-71 prevents glucocorticoid-induced bone loss by inhibiting type H vascular endothelial cell senescence through maintaining mitochondria-associated membrane-mediated calcium homeostasis. (PubMed, Cell Signal) - "Dexamethasone (DEX) induces senescence of type H vascular ECs by promoting mitochondrial calcium overload mediated by mitochondrial-associated membranes (MAMs). This study reveals a new mechanism by which ED-71 ameliorates GIOP, by maintaining MAM-mediated mitochondrial calcium homeostasis to reduce vascular bone disease. This finding not only provides theoretical support for the application of ED-71 in the prevention and treatment of GIOP but also offers important theoretical basis for the development of MAM-targeted drugs for osteoporosis, as well as suggestions for potential therapeutic targets."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology • HSPA9

Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes (clinicaltrials.gov) - P=N/A | N=310 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital | Initiation date: Aug 2025 ➔ Dec 2025

Trial initiation date • Diabetes • Metabolic Disorders • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology • Type 2 Diabetes Mellitus

ED-71 alleviates OVX-induced osteoporosis by inhibiting macrophage senescence through SIRT1/PGC-1α pathway: A potential therapeutic approach. (PubMed, Bone) - "SIRT1 inhibition with EX-527 disrupted ED-71's anti-senescence action. Additionally, ED-71 improved bone mass and aging in OVX mice. In conclusion, ED-71 alleviates macrophage senescence via the SIRT1/PGC-1α signaling axis, thereby enhancing BMSC osteogenic potential and mitigating bone loss in OVX-induced osteoporosis."

Journal • Osteoporosis • Rheumatology

Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT) (clinicaltrials.gov) - P4 | N=100 | Completed | Sponsor: Xi'an Honghui Hospital | Recruiting ➔ Completed | Trial primary completion date: Dec 2024 ➔ Jul 2025

Trial completion • Trial primary completion date • Osteoporosis • Rheumatology

Risperidone induces osteoporosis and neuropsychiatric treatment resistance via SMPD1-lysosome-mediated ferroptosis: dual rescue by active vitamin D analog ED-71. (PubMed, J Adv Res) - "This study identifies SMPD1 activation as a therapeutic target to counteract RIS-induced ferroptosis in bone and hippocampus. The dual-action mechanism of ED-71 provides a novel strategy for SZ intervention, simultaneously addressing psychiatric symptoms and osteoporotic complications."

Journal • CNS Disorders • Osteoporosis • Psychiatry • Rheumatology • Schizophrenia

Distribution effect of SOST on alveolar bone micro-bone formation in rats induced by Eldecalcitol. (PubMed, Eur J Med Res) - "This study reveals the distribution of TRAP-positive osteoclasts and sclerostin-positive osteocytes in the alveolar septal area and their correlation with bone metabolism-related factors. Eldecalcitol treatment effectively inhibits osteoclast activity, reduces bone resorption, and significantly mitigates the reduction of sclerostin expression in osteocytes induced by ovariectomy. These findings suggest that Eldecalcitol may regulate alveolar bone metabolism partially by modulating sclerostin expression, making it a promising therapeutic strategy for osteoporosis."

Journal • Preclinical • Osteoporosis • Rheumatology • SOST